作者: Sato, R. ; Sato, R ; Sarabia, L ; Aponte-Torres, Z ; Ramirez Agudelo, J L ; Law, A.W. ; López-Ibáñez de Aldecoa, A ; Haeberer, M ; Seabroke, S ; Law, A W ; López-Ibáñez de Aldecoa, A. ; Mora, L ; Aponte-Torres, Z. ; Mora, L. ; Meroc, E. ; Meroc, E ; Seabroke, S. ; Sarabia, L. ; Haeberer, M. ; Ramirez Agudelo, J.L.

This retrospective observational study aimed to quantify the costs associated with hospitalized respiratory syncytial virus (RSV) in children <18 years admitted to the Spanish National Healthcare System between 2016 and 2019 and contrast them with the costs of unspecified bronchiolitis/bronchitis/pneumonia (UBP) and influenza. The mean cost per hospitalization episode was reported by age group, risk category and prematurity. Total annual hospitalization costs were calculated from population incidence rates and the mean cost per episode. A total of 41,934 children were hospitalized with RSV, 70,160 with UBP and 8525 with influenza during 2016-2019. The highest incidence of hospitalization for RSV, UBP, and influenza occurred among infants <6 months. The mean cost per episode was highest for RSV cases aged <6 months with at least one risk factor (€4760 high vs €2827 low risk), while the mean cost ranged from €3704-4352 for high-risk and €2687-3475 for low-risk children of other ages, and from €4300-44,594 for preterm infants. In the 0-5 months age group, the mean cost per episode for UBP was €4189 and €2666 for high and low risk, and for influenza it was €3134 and €2081, respectively; while the mean cost of co-infected RSV-influenza cases was €4809 and €2887, respectively. The mean total annual estimated cost for RSV for children aged 0-17 years was €39.3 M based only on reported cases, rising to €53.8 M if we correct for under-diagnosis and all RSV-attributable cases are considered. In contrast, the mean total annual cost for influenza was €5.9 M. Compared to influenza, RSV has a substantially higher economic burden; nevertheless, the Spanish immunization schedule recommends influenza vaccine between 6 and 59 months of age and RSV monoclonal antibody only for those aged <6 months. RSV immunization is still to be implemented in older children, considering that 37 % of RSV hospitalized patients were aged ≥6 months.

2024-12-31·Human Vaccines & Immunotherapeutics

Exploring parental perspectives: Maternal RSV vaccination versus infant RSV monoclonal antibody

Article

作者: Treston, Bryony ; Geoghegan, Sarah

Respiratory Syncytial Virus poses a significant global public health threat, particularly affecting infants aged less than one year of age. Recently, two forms of passive immunization against infant RSV have been developed and brought to market; nirsevimab a long-acting monoclonal antibody (mAb) and RSV-PreF, a maternal RSV vaccine. The acceptability and uptake of these products will play a pivotal role in determining the success of any national immunization strategy aimed at safeguarding infants from RSV. It is crucial at this time to reflect on the factors that influence parental decisions surrounding immunization to facilitate more informed discussions, enhance healthcare communication, and contribute to the design of effective RSV prevention strategies that resonate with the concerns and aspirations of parents worldwide.

2024-11-01·Infectious Diseases and Therapy

Respiratory Syncytial Virus Risk Profile in Hospitalized Infants and Comparison with Influenza and COVID-19 Controls in Valladolid, Spain, 2010–2022

Article

作者: Sanz, Javier Castrodeza ; Domínguez-Gil, Marta ; Eiros, José M ; Rojo-Rello, Silvia ; Mengel, Martin ; He, Yongzheng ; Atwell, Jessica E ; Eiros, José M. ; Uppal, Sonal ; Atwell, Jessica E. ; Toquero-Asensio, Marina ; Fan, Rong ; Hernán-García, Cristina ; Martin-Toribio, Alejandro ; Haeberer, Mariana ; Liu, Qing ; Fernández-Espinilla, Virginia ; Sanz-Muñoz, Ivan

INTRODUCTIONWe aimed to describe the risk profile of RSV infections among children aged ≤ 24 months in Valladolid from January 2010 to August 2022 and to compare them with influenza and COVID-19 controls.METHODSWe conducted a retrospective cohort study of all laboratory-confirmed RSV, influenza, and COVID-19 infections. We analyzed risk factors for RSV hospitalization and severity (length-of-stay ≥ 8 days, intensive-care-unit admission, in-hospital death or readmission < 30 days) and compared severity between hospitalized RSV patients vs. influenza and COVID-19 controls using multivariable logistic regression models.RESULTSWe included 1507 patients with RSV (1274 inpatient), 32 with influenza, and 52 COVID-19 controls. Hospitalized RSV (mean age 5.3 months) and COVID-19 (4 months) were younger than influenza (9.1 months) patients. Sixteen percent of patients had RSV within the first month of life. Most infants did not have comorbidities (74% RSV, 56% influenza, and 69% COVID-19). Forty-one percent of patients with RSV and influenza were coinfected vs. 27% COVID-19 (p = 0.04). Among RSV, hospitalization risk factors were prematurity (adjusted OR 3.11 [95% CI 1.66, 4.44]) and coinfection (2.03 [1.45, 2.85]). Risks for higher severity were maternal smoking (1.89 [1.07, 3.33]), prematurity (2.31 [1.59, 3.34]), chronic lung disease (2.20 [1.06, 4.58]), neurodevelopmental condition (4.28 [2.10, 8.73]), and coinfection (2.67 [2.09, 3.40]). Breastfeeding was protective against hospitalization (0.87 [0.80, 0.95]) and severity (0.81 [0.74, 0.88]), while complete vaccination schedule was protective against severity (0.51 [0.27, 0.97]). RSV had 2.47 (1.03, 5.96) higher risk of experiencing any severe outcome compared to influenza and did not show significant differences vs. COVID-19.CONCLUSIONSRSV hospitalizations were more frequent and severe than influenza, while severity was comparable to the early pandemic COVID-19. Currently, both influenza and COVID-19 vaccines are included in the maternal and childhood Spanish immunization schedule between the ages of 6 and 59 months. RSV monoclonal antibody is recommended for ≤ 6 months but a third of patients were aged 6-24 months. Maternal RSV vaccination can protect their children directly from birth and indirectly through breastfeeding.

项与非维珠单抗相关的新闻（医药）

2023-07-18

·Pharmaceutical Technology

FDA approves AstraZeneca’s RSV monoclonal antibody treatment for infants

Akosua Mireku @AkosuaMireku1 Prior to Beyfortus’ approval, the only approved RSV preventative antibody treatment for infants was AbbVie’s Synagis (palivizumab). Credit: GOLFX via Shutterstock The US Food and Drug Administration (FDA) has approved AstraZeneca and Sanofi’s Beyfortus (nirsevimab), a form of passive immunisation for infants born during or entering their first RSV season . Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report. The therapy can also be given to infants up to 24 months of age who are vulnerable to severe RSV disease through their second RSV season. Recommended Reports Reports LOA and PTSR Model - Monoclonal Antibody Conjugate to Target GPC1 for Oncology GlobalData Reports LOA and PTSR Model - Fully-Human Anti-CD19 Chimeric Antigen Receptor in Follicular Lymphoma GlobalData View all Companies Intelligence Pfizer Inc AbbVie Inc Sanofi AstraZeneca Plc GSK plc View all Beyfortus is an intramuscular monoclonal antibody therapy that acts by neutralising the RSV-F protein. This prevents the unfolding of the protein, blocking viral entry. The antibody’s approval is based on data from three clinical studies (trials 03, 04 and 05) and a positive recommendation from a 9 June FDA Advisory Committee meeting. The European Medicines Agency approved the prophylactic treatment in October 2022. Regulatory authorities in China, Japan and several other countries are also assessing the therapy. Prior to Beyfortus’ approval, the only approved RSV preventative antibody treatment for infants was AbbVie’s Synagis (palivizumab), which was approved in 1998. However, AstraZeneca ’s newly approved medicine is the first preventative option that specifically protects the broad infant population through its first RSV season. In a February 2023 email interview with Pharmaceutical Technology , Nancy Jaser, a senior infectious disease analyst at GlobalData, predicted that upon its approval, Beyfortus would replace Synagis as the standard of care passive immunisation for paediatric RSV patients. Beyfortus’s approval follows the FDA approval of the first RSV vaccine for older adults, GSK’s Arexvy. Patients aged 60 years and above are eligible to take the immunisation. This was followed a few weeks later by approval for Pfizer’s RSV vaccine Abrysvo, intended for the same population of individuals aged 60 years and above. Phase II data from Trial 03 (NCT02878330) demonstrated that infants treated with Beyfortus had a 6.9% lower incidence of medically attended RSV lower respiratory tract infection (MA RSV LRTI). It also demonstrated that Beyfortus decreased the risk of MA RSV LRTI by approximately 70% relative to placebo. In the Phase III (MELODY) Trial 04 (NCT03979313), this increased to 75% efficacy compared to placebo. Data was taken from the Phase II/III (MEDLEY) Trial 05 , showing that the drug had a favourable safety profile. GlobalData is the parent company of Pharmaceutical Technology. According to GlobalData, the only other RSV monoclonal antibody antiviral in Phase III trials is Merck’s clesrovimab. Merck is investigating the drug in a Phase II/III (NCT04767373) and a Phase III (NCT04938830) study. In a press release , AstraZeneca’s executive vice president Iskra Reic said: “Beyfortus represents an opportunity for a paradigm-shift in preventing serious respiratory disease due to RSV across a broad infant population in the US.” Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. Please check your email to download the Report.

上市批准临床结果临床3期疫苗

2022-11-04

·MedCity News

AstraZeneca & Sanofi Win European Nod for RSV-Preventing Drug for Infants

Respiratory syncytial virus’s early surge this year has some healthcare officials concerned that this season could be a rough one. Infants, who are among the most vulnerable to infection from this pathogen, now have a new protective measure. The European Commission on Friday granted marketing authorization to an AstraZeneca and Sanofi drug that protects newborns from RSV infection in their first months of life. The drug, an antibody called nirsevimab, is engineered to bind to the RSV’s fusion protein, preventing the virus from using that protein to enter cells. Partners AstraZeneca and Sanofi will market the new drug under the name “Beyfortus.” The AstraZeneca and Sanofi drug protects differently than a vaccine. A vaccine triggers the immune system to produce an antibody, offering what is called active immunization. This type of immunity can take weeks to develop. Beyfortus is the protective antibody engineered in a lab. Administered directly to the infant, this passive immunity provides immediate protection. AstraZeneca had previously commercialized a different RSV drug, Synagis. That antibody was developed to provide premature babies with protective antibodies that they lack. But Synagis has a half-life of about 20 days. It’s dosed as an intramuscular injection given before the RSV season starts, then once monthly during the RSV season. AstraZeneca has described Beyfortus as a next-generation RSV antibody. It is engineered to have a long-half life—long enough to last the entire RSV season. That longer-life is intended to protect the baby during the first six months of life, the time when an infant is most vulnerable to RSV infection. Beyfortus can also address more babies as the product’s label covers infants broadly, not just those who are born prematurely. The European Commission decision is based on clinical trial results showing that compared to a placebo, a single dose of Beyfortus met the main goal of reducing the incidence of medically attended lower respiratory tract infections during the RSV season. The companies reported that the drug’s safety was similar to a placebo. Also, clinical trial results showed that Beyfortus’s safety and tolerability were comparable to Synagis. The Beyfortus vaccine alliance between AstraZeneca and Sanofi dates to 2017, when the antibody was still in mid-stage clinical testing. Sanofi paid its new partner €120 million up front; another €495 million was tied to the achievement of milestones. According to the deal terms, AstraZeneca took the lead on development and manufacturing activities. Sanofi will lead commercialization of the product. The partners share equally in development costs and profits from sales. AstraZeneca and Sanofi aren’t the only companies trying to improve the way infants are protected from RSV. Earlier this week, Pfizer reported positive Phase 3 data for its RSV vaccine for infants, called RSVpreF. That vaccine offers a different form of passive immunization. This maternal vaccine is administered to a healthy mother, whose immune system produces antibodies that pass through the placenta and to the baby. Pfizer said it plans to seek FDA approval by the end of this year, followed by regulatory submissions with other global authorities in coming months.

抗体疫苗

100 项与非维珠单抗相关的药物交易

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